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Job Description

About the Role:

The Associate Director of Device Clinical Development (DCD) in the Drug Product and Device Development (DPDD) group provides strategic clinical leadership for global device and combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive product training frameworks, and ensuring rigorous adherence to design control principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards.

Core Responsibilities:

Device Clinical Strategy & Risk Management:

Develop Device Clinical Development Strategy for Combination Products and Medical Devices

Develop comprehensive risk management strategies for devices and combination products including patient harm assessment in Hazard Analysis

Support translation of clinical and user needs into technical requirements

Coordinate risk mitigation activities across clinical, regulatory, quality, and engineering functions

Perform safety reviews on device and combination products from clinical trials and from the field

Training Development:

Design evidence-based product use training programs for patients, healthcare professionals, and clinical trial staff

Develop innovative instructional methodologies aligned with developmentally tailored learning principles

Establish metrics to evaluate training effectiveness and implement continuous improvement

Clinical Quality Assurance & Compliance:

Implement quality management systems for clinical activities related to device development

Develop and maintain clinical SOPs and clinical trial related device documentation

Support quality audits and implement corrective and preventive actions (CAPAs)

Clinical Trial Support:

Develop device-specific training materials and review protocols for clinical trials

Implement train-the-trainer programs for clinical research sites

Provide real-time clinical guidance on device-related aspects during trials

Design Control Adherence:

Ensure clinical input is incorporated throughout the design control processes

Review and approve user requirements, design specifications, and verification/validation plans

Maintain traceability between clinical needs and technical specifications

Human Factors & Usability:

Support use workflow development and usability engineering processes

Support formative and summative human factors study training

Regulatory Engagement:

Support audits from internal teams and Health Authorities related to device clinical development

Prepare clinical sections for regulatory submissions (IDE, 510(k), PMA, IND, NDA, BLA)

Represent clinical perspectives in regulatory meetings and correspondence

Vendor Management:

Provide subject matter expertise and mentorship to vendors performing clinical functions

Establish vendor oversight frameworks and performance metrics

Conduct vendor qualification, selection, and performance evaluation

Cross-functional Collaboration:

Facilitate seamless integration between clinical functions and device development teams

Serve as clinical liaison to Global Device Team, including engineering, regulatory affairs, quality, and commercial functions

Coordinate interdepartmental initiatives to optimize device clinical development timelines

Process Innovation:

Lead initiatives to improve efficiency of clinical development processes

Implement data-driven approaches to optimize clinical activities

Develop innovative solutions to streamline device clinical development

Team Leadership & Development:

Promote a culture of scientific excellence, adherence to regulatory and quality standards, and patient-focused innovation.

Lead, mentor, and develop organization on device clinical development best practices, strategies, and trends

Required Qualifications:

An advanced degree in medical, clinical, healthcare science, or a related field:

Doctorate degree with 7+ years of experience, ORMaster's degree with 13+ years of experience, ORBachelor's degree with 15+ years of experience

Minimum 5 years of combination product, medical device, or pharmaceutical industry experience

Experience with both medical devices, drug-device combination products, digital health technologies across multiple therapeutic areas

Experience with device design control processes and risk management methodologies

Thorough understanding of FDA, EMA, and international regulations for medical devices and combination products

Proven ability to thrive in a fast-paced environment supporting multiple development programs

Preferred Qualifications:

A Health Care Provider (HCP) that is practicing part-time (no more than 5 days per month) is strongly preferred

Advanced program management skills

Strong background in clinical research methodology

Exceptional stakeholder management and conflict resolution capabilities

This role offers an exceptional opportunity to drive innovation at the intersection of medical devices and pharmaceutical development, with significant impact on patient care and treatment outcomes.​​​​​​​​​​​​​​​​

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Lexington, MA

U.S. Base Salary Range:

$153,600.00 - $241,340.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

LocationsLexington, MA

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.